CABOMETYX Rx

Not substitutable with cabozantinib caps. Permanently discontinue if the following occurs: GI perforation, GI fistula (Grade 4), severe hemorrhage (Grade 3/4), acute MI, serious thromboembolic events that require medical intervention, hypertensive crisis or severe hypertension despite optimal medical management, nephrotic syndrome, reversible posterior leukoencephalopathy syndrome; with nivolumab: if AST or AST >10×ULN or >3×ULN with total bilirubin ≥2×ULN. Withhold for intolerable Grade 2 reactions, Grade 3/4 reactions, or osteonecrosis of the jaw; with nivolumab: for ALT or AST >3×ULN but ≤10×ULN with total bilirubin <2×ULN. Recent history of hemorrhage (including hemoptysis, hematemesis, melena): do not administer. Monitor for GI perforations/fistulas. Monitor BP regularly; withhold for hypertension inadequately controlled with medical management; resume at reduced dose when resolved. Higher risk of hepatotoxicity (with nivolumab); monitor liver enzymes prior to initiation and more frequently during treatment. Risk of adrenal insufficiency (with nivolumab); withhold therapy based on severity. Withhold therapy if intolerable Grade 2 diarrhea, unmanageable Grade 3/4 diarrhea, or intolerable Grade 2/3 palmar-plantar erythrodysesthesia (PPE) develops until improvement to Grade 1; resume at reduced dose. Monitor urine protein regularly. Perform oral exam prior to initiation and periodically during therapy. Impaired wound healing: withhold for ≥3 weeks prior to elective surgery (including dental); do not give for ≥2 weeks after major surgery and until adequate healing. Severe hepatic impairment (Child-Pugh C): avoid. Severe renal impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).

Not substitutable with cabozantinib caps. Permanently discontinue if the following occurs: GI perforation, GI fistula (Grade 4), severe hemorrhage (Grade 3/4), acute MI, serious thromboembolic events that require medical intervention, hypertensive crisis or severe hypertension despite optimal medical management, nephrotic syndrome, reversible posterior leukoencephalopathy syndrome; with nivolumab: if AST or AST >10×ULN or >3×ULN with total bilirubin ≥2×ULN. Withhold for intolerable Grade 2 reactions, Grade 3/4 reactions, or osteonecrosis of the jaw; with nivolumab: for ALT or AST >3×ULN but ≤10×ULN with total bilirubin <2×ULN. Recent history of hemorrhage (including hemoptysis, hematemesis, melena): do not administer. Monitor for GI perforations/fistulas. Monitor BP regularly; withhold for hypertension inadequately controlled with medical management; resume at reduced dose when resolved. Higher risk of hepatotoxicity (with nivolumab); monitor liver enzymes prior to initiation and more frequently during treatment. Risk of adrenal insufficiency (with nivolumab); withhold therapy based on severity. Withhold therapy if intolerable Grade 2 diarrhea, unmanageable Grade 3/4 diarrhea, or intolerable Grade 2/3 palmar-plantar erythrodysesthesia (PPE) develops until improvement to Grade 1; resume at reduced dose. Monitor urine protein regularly. Perform oral exam prior to initiation and periodically during therapy. Impaired wound healing: withhold for ≥3 weeks prior to elective surgery (including dental); do not give for ≥2 weeks after major surgery and until adequate healing. Severe hepatic impairment (Child-Pugh C): avoid. Severe renal impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).